The Need for Clarity: Where Should FDA Focus Its Resources When Implementing the Compounding Provisions of the Drug Quality and Security Act? December 2013

In this Policy Forum, Palmer discusses policy questions raised by the “Compounding Quality Act” or Title I of the recently enacted Drug Quality and Security Act (DQSA).  Specifically, Palmer states that “the law raises significant concerns about oversight and enforcement, and the ability of pharmacies and ‘outsourcing facilities’—a compounding category created by the DQSA—to meet the recognized need for compounded medications.” The author provides an overview of the Act’s revisions to sections 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) and the addition of the new section 503B.
Palmer asserts that while DQSA Title I provides some clarity, FDA and state boards of pharmacy must quickly come to terms on the enforcement authority and priorities under Section 503A.  Palmer also recommends that FDA promulgate a list of “permissible” substances because the Act requires outsourcing facilities compounding from bulk substances to articulate a “clinical need.”  Palmer further explains that the limited number of outsourcing facilities FDA anticipates will register initially will not be able to meet the demand for compounded drugs listed on FDA’s drug shortage list, which will negatively affect the availability of medications in short supply. 

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